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FDA 510(k)

OZARK脊椎板系統；PYRENEES®脊椎板系統；EVEREST®脊椎系統；MESA®脊椎系統；MESA®矮身材脊椎系統；CASPIAN®脊椎系統；DENALI®脊椎系統；DENALI® MI脊椎系統；YUKON OCT脊椎系統；Xia® 3脊椎系統；K2M病人專屬；CASCADIA™間體系統；CAYMAN®板系統；CAYMAN®板系統-MI

K 號：K242361 · 2024-11-07

申請人Stryker Spine
決定日期2024-11-07
產品代碼KWQ
諮詢委員會或
決定相當於

器材摘要

OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Spine. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242361. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI?

OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Stryker Spine. The 510(k) number is K242361.

When did OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI receive FDA 510(k) clearance?

OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242361.

Who is the listed applicant for OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI?

FDA 510(k) 記錄將 Stryker Spine 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI?

The FDA product code for OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI is KWQ.

相關臨床試驗

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其他以 Stryker Spine 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262061Tritanium® C 頸椎前方金層；Tritanium® PL 金層；Tritanium® TL 弯曲後腰金層；Aero® -C 頸椎金層系統；AVS® Anchor-C 頸椎金層系統；AVS® TL PEEK 间隔器；AVS® PL PEEK 间隔器；AVS® Navigator PEEK 间隔器；AVS® AS PEEK 间隔器；Monterey™ AL 間體系統；Aleutian IBF 系統；Cascadia 間體系統；Chesapeake 稳定系統；Sahara 稳定系統；SANTORINI™ 去骨金層系統；MOJAVE 間體系統；VLIFT VERTEBRAL BODY REPLACEMK261008Vitoss® BiModal 生物活性骨移植代用品泡沫條；Vitoss® BiModal 生物活性骨移植代用品；Vitoss BBTrauma® 生物活性骨移植代用品；Vitoss® BA2X 生物活性骨移植代用品；Vitoss® 生物活性泡沫骨移植代用品包；Vitoss® 生物活性泡沫骨移植代用品；Vitoss® 泡沫骨移植代用品；Vitoss® 骨移植代用品填充罐；Vitoss® 骨移植代用品K242280Vitoss® BiModal 生物活性骨移植代用品泡沫條，Vitoss® BiModal 生物活性骨移植代用品，Vitoss BBTrauma® 生物活性骨移植代用品，Vitoss® BA2X 生物活性骨移植代用品，Vitoss® 生物活性骨移植代用品包裝，Vitoss® 生物活性骨移植代用品，Vitoss® 泡沫骨移植代用品，Vitoss® 骨移植代用品填充罐，Vitoss® 骨移植代用品，Vitoss® 骨移植代用品 - 合成多孔片K222684XIA® 4.5脊椎系統，XIA® 4.5皮質軌跡，XIA® 3脊椎系統，Serrato®脊椎系統，XIA®成長桿轉換組，XIA® II脊椎系統，XIA®精準系統，XIA®前側，Diapason®脊椎系統，Opus™脊椎系統，Radius®脊椎系統，Mantis®脊椎系統，Mantis® Redux，Trio® & Trio+脊椎固定系統，ES2™脊椎系統，ES2™可擴充脊椎系統，Oasys®枕頸胸系統，Nile®近端固定脊椎系統，Nile®替代固定脊椎系統K221490Tritanium C 頸椎前方金層，Tritanium PL 金層，Tritanium TL 弯曲後腰金層，Tritanium X PL 可擴張後腰金層，Tritanium X TL 可擴張弯曲後腰金層，Stryker Spine VLIFT 骨體置換系統，VLIFT-s 骨體置換系統，Ascential IBD PEEKc Spacer，Aero-AL 腰椎金層系統，Aero-LL 腰椎金層系統，Aero-C 頸椎金層系統，AVS Aria PEEK Spacer，AVS Anchor-C 頸椎金層系統，AVS Anchor-L SpacerK203205導航脊椎儀器

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相關器械（代碼：KWQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLCK252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

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